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FDA 510(k)

Instylla Delivery Kit

K-Number: K191659 · 2019-10-10

Decision Date2019-10-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instylla Delivery Kit is a medical device manufactured by Instylla, Inc.. It received FDA 510(k) clearance on 2019-10-10 under approval number K191659. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instylla Delivery Kit?

Instylla Delivery Kit is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Instylla, Inc.. The 510(k) number is K191659.

When was Instylla Delivery Kit approved by the FDA?

Instylla Delivery Kit received FDA 510(k) clearance on 2019-10-10, under approval number K191659.

What company makes Instylla Delivery Kit?

Instylla Delivery Kit is manufactured by Instylla, Inc..

What is the FDA product code for Instylla Delivery Kit?

The FDA product code for Instylla Delivery Kit is FMF.

Other Devices by Instylla, Inc.

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Related Devices (Code: FMF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.